Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial.
Mpoya A., Kiguli S., Olupot-Olupot P., Opoka RO., Engoru C., Mallewa M., Chimalizeni Y., Kennedy N., Kyeyune D., Wabwire B., M'baya B., Bates I., Urban B., von Hensbroek MB., Heyderman R., Thomason MJ., Uyoga S., Williams TN., Gibb DM., George EC., Walker AS., Maitland K.
BACKGROUND: In sub-Saharan Africa, where infectious diseases and nutritional deficiencies are common, severe anaemia is a common cause of paediatric hospital admission, yet the evidence to support current treatment recommendations is limited. To avert overuse of blood products, the World Health Organisation advocates a conservative transfusion policy and recommends iron, folate and anti-helminthics at discharge. Outcomes are unsatisfactory with high rates of in-hospital mortality (9-10%), 6-month mortality and relapse (6%). A definitive trial to establish best transfusion and treatment strategies to prevent both early and delayed mortality and relapse is warranted. METHODS/DESIGN: TRACT is a multicentre randomised controlled trial of 3954 children aged 2 months to 12 years admitted to hospital with severe anaemia (haemoglobin